Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Damon Corp. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

36 daysmedian FDA review time
57 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874865DAMON D.E.T.E.C.T IMAGE ENHANCERDamon Corp.1987-12-23260
K831826ADRENOCORTICOTROPIN RADIO-IMMUNOASSAYDamon Corp.1983-07-18410
K820686LIQUISOL PROGESTERONE RADIOIMMUNODamon Corp.1982-04-01210
K802661LIQUISOL TESTOSTERONE RADIOIMM. TEST KITDamon Corp.1980-12-10430
K790250LIQUISOL CORTISOL RIA TEST KITDamon Corp.1979-04-04570
K782124IEC CENTRA-7 CENTRIFUGE MODEL 2362Damon Corp.1979-02-26610
K781012RIA TEST KIT SYS. DAMON KIQUISOL FREEDamon Corp.1978-07-27410
K780207LIQUISOL DIGOXIN RIA TEST KITDamon Corp.1978-02-23160
K770918LIQUI SOL T4 RIA TEST KITDamon Corp.1977-06-17290
K770606ANALYZEO, PLASMA, BLOOD, COLYSAGRAPHDamon Corp.1977-05-06360
K761013SPINETTE CENTRIFUGEDamon Corp.1976-11-1670

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda